Erik Hansson, deputy head of the unit responsible for medical devices within the European Commission’s Directorate General Grow, told during Team-NB 15th Anniversary meeting.

He advised companies to try to turn to notified bodies that have a good track record and good capacity to take on new work, and for instance consider looking at those that are adhering to the TEAM-NB code of conduct.

2022-04-08T18:20:33+01:00

Transatlantic Trade and Investment Partnership (TTIP) initial position paper on Medical Devices

The objective is to promote regulatory convergence in the medical devices sector.   This could cover: • Recognition of manufacturers' quality management systems (QMS) audits • Convergence of systems for identifying and tracing medical devices (Unique Device Identification - UDI) • Convergence of models for marketing submissions (Regulated Product Submission - RPS) Namely the possible [...]

2022-04-08T18:20:35+01:00
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